Evaluating the Safety, Tolerability and Preliminary Efficacy of Plasma in Improving the Appearance of Onychomycosis
Primary Purpose
Onychomycosis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOE Plasma Delivery System A
MOE Plasma Delivery System B
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
Inclusion Criteria:
- Subject must be between 18 and 70 years of age inclusive, of either sex, and of any race;
- Subject must have distal subungual infection that affects approximately 25% to 60% of at least one great toenail
- Dermatophyte infection or infection with C. Albicans in the target great toenail confirmed by identification of a dermatophyte organism in culture;
- Subject must have at least 3 mm from the proximal end of the target toenail free of infection;
- Subject must have a target toenail that is assessed as capable of growing approximately 1 mm/month, (e.g., the subject needs to report cutting his or her toenails at least once per month);
- Subject must be willing to give written informed consent and able to adhere to procedures and visit schedules;
- Subject must consent to having the toenails photographed during the study period;
- Woman of childbearing potential: If currently sexually active, must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 30 days after stopping the study treatments; If not currently active, must agree to use medically accepted method of contraception should she become sexually active during study participation. Methods include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, oral or systemic hormonal contraceptive (plus an additional reliable barrier method), and surgical sterilization (e.g., hysterectomy or tubal ligation);
- Woman of childbearing potential must have a negative serum or urine pregnancy test prior to start of study.
Exclusion Criteria:
- Subject with more than 6 infected toenails
- Subject with fingernail onychomycosis
Subject with one or more of the following conditions on the primary target toenail:
- white superficial onychomycosis
- dermatophytoma or "yellow spike/streak"
- primarily lateral or bi-lateral disease
- toenail thickness greater than 3 mm
- inability to become normal in the opinion of the investigator
- Subject with psoriasis, pincer nail, prior nail surgery, severe moccasin-type tinea pedis requiring treatment, symptomatic interdigital tinea pedis, lichen planus, or other abnormalities that could result in a clinically abnormal nail;
- Subject with peripheral vascular disease or peripheral circulatory impairment;
- Subject with uncontrolled diabetes mellitus, subjects with diabetes controlled by insulin or with known diabetic peripheral neuropathy
- Subject with any known immunodeficiency;
- Any pacemakers, or any metallic implants or prostheses in the vicinity of the treatment site (such as ankle, foot, etc.);
- Subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with study evaluations or optimal participation in the study;
- Subject who has received systemic antifungal therapy within 6 months (except single diflucan tablet for vaginal candida) or topical antifungal therapy applied to the foot or toenails within 1 month of study entry;
- Subject who has received radiation therapy, chemotherapy, and/or immunosuppressive drugs within 6 months of study, and/or oral corticosteroids for >1 month within the 6 months of study (exception: inhaled steroids);
- Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study;
- Subject who is unwilling to abstain from any cosmetic nail or foot treatments outside those provided by the study clinic, beyond basic nail trimming (i.e. no spa foot treatments, no pedicures/toenail polish use, no other topical prescription toenail medication);
- Woman who is breastfeeding, pregnant, or intends to become pregnant (check via urine test only);
- Subject who is part of the staff personnel directly involved with this study or a family member of the investigational study staff;
Sites / Locations
- MOE Medical Devices Site 5Recruiting
- MOE Medical Devices Site 4
- MOE Medical Devices Investigational Site 3
- MOE Medical Devices Site 6
- MOE Medical Devices Investigational Site 1Recruiting
- MOE Medical Devices Investigational Site 2Recruiting
- MOE Medical Devices Site 7
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Plasma treatment using Plasma delivery system A 3 treatments/week for 2 weeks, then monthly
Plasma treatment using Plasma delivery system A 2 treatments/week for 2 weeks, then monthly
Plasma treatment using Plasma delivery system B 3 treatments/week for 2 weeks, then monthly
Outcomes
Primary Outcome Measures
Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0
The primary objective of this study is to compare the short-term safety and tolerability of application of non-ablative electrical plasma to human nails among the different dosing regimes.
Secondary Outcome Measures
Efficacy as assessed by Clinical, Mycological and Complete Cure Rates assessed in accordance with FDA Guidance for onychomycosis trials issued March 7, 2016
The secondary objective of this study is to evaluate the preliminary efficacy of non-ablative electrical plasma in improving the appearance and treatment of onychomycosis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02724384
Brief Title
Evaluating the Safety, Tolerability and Preliminary Efficacy of Plasma in Improving the Appearance of Onychomycosis
Official Title
A Multi-Center Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Improving the Appearance of Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moe Medical Devices
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and preliminary efficacy of using electrical plasma to treat toenail fungus.
Detailed Description
75 patients will be recruited at several sites. Patients will be split into 3 groups that have different treatment doses. Patient participation in the study will last 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Plasma treatment using Plasma delivery system A 3 treatments/week for 2 weeks, then monthly
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Plasma treatment using Plasma delivery system A 2 treatments/week for 2 weeks, then monthly
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Plasma treatment using Plasma delivery system B 3 treatments/week for 2 weeks, then monthly
Intervention Type
Device
Intervention Name(s)
MOE Plasma Delivery System A
Intervention Description
Plasma treatment
Intervention Type
Device
Intervention Name(s)
MOE Plasma Delivery System B
Intervention Description
Plasma treatment
Primary Outcome Measure Information:
Title
Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0
Description
The primary objective of this study is to compare the short-term safety and tolerability of application of non-ablative electrical plasma to human nails among the different dosing regimes.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Efficacy as assessed by Clinical, Mycological and Complete Cure Rates assessed in accordance with FDA Guidance for onychomycosis trials issued March 7, 2016
Description
The secondary objective of this study is to evaluate the preliminary efficacy of non-ablative electrical plasma in improving the appearance and treatment of onychomycosis.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must be between 18 and 70 years of age inclusive, of either sex, and of any race;
Subject must have distal subungual infection that affects approximately 25% to 60% of at least one great toenail
Dermatophyte infection or infection with C. Albicans in the target great toenail confirmed by identification of a dermatophyte organism in culture;
Subject must have at least 3 mm from the proximal end of the target toenail free of infection;
Subject must have a target toenail that is assessed as capable of growing approximately 1 mm/month, (e.g., the subject needs to report cutting his or her toenails at least once per month);
Subject must be willing to give written informed consent and able to adhere to procedures and visit schedules;
Subject must consent to having the toenails photographed during the study period;
Woman of childbearing potential: If currently sexually active, must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 30 days after stopping the study treatments; If not currently active, must agree to use medically accepted method of contraception should she become sexually active during study participation. Methods include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, oral or systemic hormonal contraceptive (plus an additional reliable barrier method), and surgical sterilization (e.g., hysterectomy or tubal ligation);
Woman of childbearing potential must have a negative serum or urine pregnancy test prior to start of study.
Exclusion Criteria:
Subject with more than 6 infected toenails
Subject with fingernail onychomycosis
Subject with one or more of the following conditions on the primary target toenail:
white superficial onychomycosis
dermatophytoma or "yellow spike/streak"
primarily lateral or bi-lateral disease
toenail thickness greater than 3 mm
inability to become normal in the opinion of the investigator
Subject with psoriasis, pincer nail, prior nail surgery, severe moccasin-type tinea pedis requiring treatment, symptomatic interdigital tinea pedis, lichen planus, or other abnormalities that could result in a clinically abnormal nail;
Subject with peripheral vascular disease or peripheral circulatory impairment;
Subject with uncontrolled diabetes mellitus, subjects with diabetes controlled by insulin or with known diabetic peripheral neuropathy
Subject with any known immunodeficiency;
Any pacemakers, or any metallic implants or prostheses in the vicinity of the treatment site (such as ankle, foot, etc.);
Subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with study evaluations or optimal participation in the study;
Subject who has received systemic antifungal therapy within 6 months (except single diflucan tablet for vaginal candida) or topical antifungal therapy applied to the foot or toenails within 1 month of study entry;
Subject who has received radiation therapy, chemotherapy, and/or immunosuppressive drugs within 6 months of study, and/or oral corticosteroids for >1 month within the 6 months of study (exception: inhaled steroids);
Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study;
Subject who is unwilling to abstain from any cosmetic nail or foot treatments outside those provided by the study clinic, beyond basic nail trimming (i.e. no spa foot treatments, no pedicures/toenail polish use, no other topical prescription toenail medication);
Woman who is breastfeeding, pregnant, or intends to become pregnant (check via urine test only);
Subject who is part of the staff personnel directly involved with this study or a family member of the investigational study staff;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sin Park, PhD
Phone
914-594-1985
Email
allsra@gmail.com
Facility Information:
Facility Name
MOE Medical Devices Site 5
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Individual Site Status
Recruiting
Facility Name
MOE Medical Devices Site 4
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Individual Site Status
Terminated
Facility Name
MOE Medical Devices Investigational Site 3
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15222
Country
United States
Individual Site Status
Terminated
Facility Name
MOE Medical Devices Site 6
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet DuBois
Facility Name
MOE Medical Devices Investigational Site 1
City
College Station
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Individual Site Status
Recruiting
Facility Name
MOE Medical Devices Investigational Site 2
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Individual Site Status
Recruiting
Facility Name
MOE Medical Devices Site 7
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Pollak
12. IPD Sharing Statement
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Evaluating the Safety, Tolerability and Preliminary Efficacy of Plasma in Improving the Appearance of Onychomycosis
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